Who is sponsoring NCT05162027?

NCT05162027 is sponsored by University of Maryland, Baltimore.

What drugs are being tested in NCT05162027?

Interventions in NCT05162027: Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe, Placebo.

What condition does NCT05162027 study?

NCT05162027 studies Temporomandibular Disorders.

Is NCT05162027 still recruiting?

NCT05162027 is currently terminated. Last updated 2 April 2024.

Are results published for NCT05162027?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2024-04-02 · How we verify

NCT05162027: TMD CARE

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Erenumab-aooe for Temporomandibular Disorders Management: TMD Cgrp Antibody RElief (TMD CARE)

Terminated Phase 2 Results posted Last updated 2 April 2024

What this trial tests

Phase 2 trial testing Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe in Temporomandibular Disorders in 5 participants. Terminated before completion.

Timeline

26 May 2022

Primary endpoint
3 January 2023

3 January 2023

Quick facts

Lead sponsor	University of Maryland, Baltimore
Phase	Phase 2
Status	Terminated
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	triple
Primary purpose	treatment
Enrollment	5
Start date	26 May 2022
Primary completion	3 January 2023
Estimated completion	3 January 2023
Sites	1 location across United States

Drugs / interventions tested

Erenumab-Aooe 70 MG in 1 mL Prefilled Syringe — full drug profile →
Placebo

Conditions studied

Temporomandibular Disorders — all drugs for Temporomandibular Disorders →

Sponsor

University of Maryland, Baltimore

Who can join

Adults 18 to 65, any sex, with Temporomandibular Disorders. Patients with the condition only — healthy volunteers not accepted.

Adverse events — posted to ClinicalTrials.gov

Time frame: From the first dose of study drug/placebo up to 4 weeks after the last dose (a total of 16 weeks).. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Erenumab-aooe

Serious: 0/1 (0%)

Deaths: 0/1

Placebo

Serious: 0/1 (0%)

Deaths: 0/1

Other adverse events (1 terms — click to expand)

Reaction	System	Erenumab-aooe	Placebo
Other	Gastrointestinal disorders	—	—

Data from ClinicalTrials.gov NCT05162027 adverse events section.

Sponsor's own description

Evaluate erenumab- aooe efficacy as a therapeutic approach, for the management of painful chronic temporomandibular disorders (TMD). The study will be a randomized, double blind, placebo-controlled trial comparing erenumab-aooe vs Placebo. A total of 60 patients (30 per each arm) aged 18-65 years old of either sex, and any race or ethnicity presenting chronic temporomandibular disorders (TMD), (meeting the Diagnostic Criteria for Temporomandibular Disorders (DC/TMD) for Clinical and Research Applications of chronic TMD (myalgia +/- arthralgia) will be randomly assigned in a 1:1 parallel, double-blind clinical trial, to receive either erenumab-aooe or placebo. Participants will attend 6 clinic visits (Visit 0-Visit 5) over a period of 21 weeks (20 +/- 1 weeks). Changes in pain intensity and other pain outcomes related to TMD will be assessed. Blood samples will be collected, and participants will need to keep a daily symptom diary and answer some other questionnaires.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Calcitonin Gene-Related Peptide-Mediated Trigeminal Ganglionitis: The Biomolecular Link between Temporomandibular Disorders and Chronic Headaches.
Sangalli L, Eli B, Mehrotra S, Sabagh S, et al · · 2023 · cited 4× · PMID 37569575 · DOI 10.3390/ijms241512200

Verify or expand the search:

Other recruiting trials for Temporomandibular Disorders

Currently open trials in the same condition.

NCT07452510 — Comparison of Dry Needling and Two Botulinum Toxins for Bruxism · NA · active not recruiting
NCT06553950 — Mandibular Splint vs Botox Injection in Lateral Pterygoid on Cervical Muscle Activity in Patients With Temporomandibular · NA · recruiting
NCT05720065 — Peripheral TMD Pain Mechanisms and the Effect by Botulinum Toxin A · Phase 2 · recruiting

Other University of Maryland, Baltimore trials

Trials by the same sponsor.

NCT07537413 — Ceftriaxone Dosage for Non-Critical Community-Acquired Pneumonia · Phase 4 · not yet recruiting
NCT07221799 — OER Glibenclamide for Neuropathic Pain in Multiple Sclerosis · Phase 1 · not yet recruiting
NCT07094672 — Development of an Opioid Withdrawal Clinical Outcome Assessment · not yet recruiting
NCT06583239 — Hub-Based Engagement Navigator Service to Reduce CSC Disengagement · NA · not yet recruiting
NCT07536412 — Decision Aid Efficacy in Low Risk Thyroid Cancer · NA · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05162027 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of Maryland, Baltimore
Last refreshed: 2 April 2024

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05162027.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing